(182 days)
The Hogue Surgical EndlessFiber® SMA-BAR family of medical devices is intended for clinical use in laser surgery procedures for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: Y AG, Ho: Y AG, Diode, and KTP laser systems have been cleared for medical use, provided they are fitted with a launch port aperture compatible with the EndlessFiber® SMA 905 connector.
The Hogue Surgical EndlessFiber® Reusable Surgical Laser Fiber is a family of optical fibers that are terminated at one end with industry standard SMA 905 connectors. Each connector is fitted with a collar, a strain relief to the fiber, and a dust cover to protect the mechanically-cleaved fiber endfaces.
The provided text describes a 510(k) premarket notification for a medical device, the Hogue Surgical EndlessFiber® Reusable Surgical Laser Fiber. This document focuses on demonstrating substantial equivalence to a previously approved predicate device (K050738), rather than presenting a study where specific acceptance criteria are defined and then proven by the device's performance in a clinical trial or a detailed standalone performance study with a test set, expert readers, and ground truth in the typical sense of AI/medical imaging device evaluations.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) are not directly applicable or available in the provided text as they relate to typical clinical performance studies for diagnostic or AI-driven systems. This document is a regulatory submission for a surgical instrument, which primarily focuses on safety and functional equivalence.
Here's the information that can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are derived from the "PERFORMANCE DATA" section, which focuses on safety and functional characteristics, demonstrating that the device is no less safe or effective than the predicate.
| Acceptance Criteria (Functional/Safety Benchmarks) | Reported Device Performance (Hogue Surgical EndlessFiber®) |
|---|---|
| Optical input attenuation of less than 10% | Less than 10% @ 30W, 30 minutes, 1064nm, discharging into air |
| SMA905 connection temperature rise of less than 10°F | Less than 10°F @ 30W, 30 minutes, 1064nm, discharging into air |
| Comparable functional (optical transmission) performance to predicate | "Samples of this device and samples of its predicate, in their various sizes, have been compared experimentally for functional (optical transmission) performance." |
| "Bench testing performance data demonstrates that the two types of device are comparable in their performance." | |
| Operates in the same manner as the predicate | "The Hogue Surgical, LLC surgical laser delivery fiber operates in the same manner as the predicate device" |
2. Sample size used for the test set and the data provenance
The document mentions "Samples of this device and samples of its predicate, in their various sizes," were compared experimentally. However, specific sample sizes (e.g., number of fibers tested) and the provenance of the data (country of origin, retrospective/prospective) are not provided. This was likely bench testing performed by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a bench testing study for a surgical instrument, not a study evaluating human interpretation against a ground truth.
4. Adjudication method for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a surgical laser fiber, not an AI or diagnostic imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept doesn't directly apply as the device is a physical instrument. However, the "PERFORMANCE DATA" section describes standalone bench testing of the device's optical and thermal properties without human interaction during the measurement process. The results reported (optical input attenuation, temperature rise) are from this standalone functional testing.
7. The type of ground truth used
For the functional and safety performance, the "ground truth" is established by bench testing measurements against specified physical and performance thresholds (e.g., maximum attenuation, maximum temperature rise) and comparison to the predicate's known performance.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.